Affordable costs and minimal regulatory clearances are factors which are driving the Indian Biosimilar industry, according to Dipta Chaudhry, senior consultant, pharma and biotech practice, South Asia and Middle East, Frost and Sullivan.


The country’s biosimilar market is estimated at US$ 363 million and has the potential to grow to $3.7 billion in 2015. There are over 130 companies in the biopharmaceutical market in India. However, only 7 to 10 companies are involved in the manufacture of recombinant products. These include Biocon, Dr Reddy’s, Intas, Ranbaxy, Wockhardt, Shanta Biotech and Cipla among others.


The two key factors that could work favourably for Indian biosimilar companies in the domestic market are the relative cost advantage of biosimilar development compared to competitors elsewhere, hence reducing the appeal of imported biosimilars. There is also the need for low regulatory requirements for establishing bioequivalence, which also helps to keep development costs low, added Chaudhry who was recently here in Bangalore.


The global biotechnology industry, currently estimated at US$ 125 billion has shown robust growth over the past five years. Scientific advances and changes in market conditions, have produced a rapidly maturing industry, with pharma biotech being one of the largest sectors. In fact, the Indian biotechnology sector is one of the fastest growing knowledge-based sectors in India and is expected to play a key role in shaping India's rapidly developing economy. The biotech industry is ranked among the top 12 biotech destinations in the world, and the Indian biotech sector is the third largest in the Asian region.


Frost & Sullivan estimates the global biotech industry to reach US$ 433 billion by 2015, while the global biosimilar Industry is expected to be valued at US$ 19.6 billion by 2015.


The robust growth in the Indian biotech industry has resulted in the creation of a plethora of opportunities, both at the domestic and international arena, for biotech businesses; especially in the areas of biopharmaceuticals, biosimilars.


In the biosimilar space, vaccines accounted for the largest segment, with an estimated sales of Rs.2,180 crore or US$ 481.50 million over last year’s Rs. 2,000 crore or US$ 441.85 million. The vaccine segment, human as well as animal vaccines, accounted for 50-60 per cent of the total biopharmaceutical market.


The total estimated sales from the human vaccine business stood at Rs.1,750 crore or US$ 386.69 million which is over the figure of 2008- 2009 that was US$ 342.41 million or Rs.1,550 crore. Domestic sales of human vaccines just crossed Rs.1,000 crore or US$ 220.93 million.